Senior Quality Engineer, NPD – Medical Devices

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences Irvine, CA is seeking a Principal Quality Engineer, NPD to lead quality engineering for new product development of transcatheter heart valve devices. You will develop design controls, lead risk management, and collaborate with R&D, manufacturing, and cross-functional teams to ensure regulatory compliance and robust designs.

Ideal candidates hold an engineering or scientific degree with several years of relevant experience, strong problem solving, and hands-on familiarity

Qualifications

• Bachelor's degree in Engineering or Scientific field required; advanced degrees preferred.
• Master's degree or PhD considered with relevant experience.
• Strong documentation, communication, and interdisciplinary collaboration skills.

Responsibilities

• Develop, update, and maintain design control documentation through product development processes.
• Collaborate with R&D, manufacturing, and cross-functional stakeholders to drive process and test method development, product builds, and product launches.
• Investigate complex product quality and compliance issues during new product development and propose corrective actions.
• Identify opportunities for redesigns or improvements to equipment, fixtures, or processes to reduce risk and improve manufacturability.
• Train, coach, and guide technicians and ensure adherence to design control and quality systems.

Skills

Documentation

Communication

Statistical techniques

Leadership

Quality engineering principles

Cross-functional collaboration

Process improvement

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree in Engineering or Scientific field

Ph.D. in Engineering or Scientific field

Tools

MS Office Suite

Microsoft Project

CAD software

Lab/industrial equipment experience

Job description

Edwards Lifesciences Irvine, CA is seeking a Principal Quality Engineer, NPD to lead quality engineering for new product development of transcatheter heart valve devices. You will develop design controls, lead risk management, and collaborate with R&D, manufacturing, and cross-functional teams to ensure regulatory compliance and robust designs.

Ideal candidates hold an engineering or scientific degree with several years of relevant experience, strong problem solving, and hands-on familiarity